M-CLARITHROMYCIN

1 Dosing Consideration  M-CLARITHROMYCIN may be given with or without meals.  In patients with a combination of hepatic (mild to moderate) and renal impairments or in the presence of severe renal impairment, decreased dosage of clarithromycin or prolonged dosing intervals might be appropriate.

2 Recommended Dose and Dosage Adjustment.  Clarithromycin is contraindicated in patients with severe hepatic failure in combination with renal impairment. See 2 CONTRAINDICATIONS. 2 Recommended Dose and Dosage Adjustment  Adults with Respiratory Tract or Skin Infections o The adult dosage of M-CLARITHROMYCIN is 250 mg to 500 mg every 12 hours (Table 1) for 7 to 14 days.

For infections caused by less susceptible organisms, the upper dosage should be used. d. = twice daily o In the treatment of Group A streptococcus infections, therapy should be continued for 10 days. The usual drug of choice in the treatment of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route.

o Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not presently available. , 250 mg once daily, or 250 mg twice daily in more severe infections.

Dosage should not be continued beyond 14 days in these patients. The safety and efficacy of 500 mg clarithromycin in patients with severe renal impairment has not been established.  Hepatic Impairment o In patients with a combination of hepatic (mild to moderate) and renal impairments, decreased dosage of clarithromycin or prolonged dosing intervals may be appropriate.

clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. o Clarithromycin is contraindicated in patients with severe hepatic failure in combination with renal impairment.

See 2 CONTRAINDICATIONS.  Eradication of Helicobacter Pylori o Triple Therapy: M-CLARITHROMYCIN/omeprazole/amoxicillin: The recommended dose is clarithromycin 500 mg twice daily in conjunction with omeprazole 20 mg daily and amoxicillin 1000 mg twice daily for 10 days.

See 14 CLINICAL TRIALS, Eradication of Helicobacter pylori, Triple Therapy: clarithromycin tablets/omeprazole/amoxicillin. For more information on omeprazole or amoxicillin, refer to their respective Product Monographs, under 4 DOSAGE AND ADMINISTRATION.

Fatalities have been reported. Elderly patients may be more susceptible to drug-associated effects on the QT interval. , < 50 bpm), or when concomitantly taking with other medicinal products associated with QT prolongation, due to the risk for QT prolongation and torsades de pointes.

See

2 Breast- feeding 12/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS.............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ...................................................................................................................

2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Consideration ................................................................................................

2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration........................................................................................................... 5 Missed Dose ..............................................................................................................

8 5 OVERDOSAGE ............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.................................. 9 7 WARNINGS AND PRECAUTIONS ..................................................................................

2 Breast- feeding 12/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................

2 TABLE OF CONTENTS.............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ...................................................................................................................

2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................

5